Health-relatedness and Long-term Objectives: Atherosclerotic renal artery stenosis is a common problem for which there is no clear consensus on diagnosis or therapy. There likely exists a progression wherein renal ischemia leads to neuroendocdne activation, hypertension, and renal insufficiency potentially resulting in acceleration of therosclerosis, further renal dysfunction, myocardial infarction, stroke and death. The current proposal tests whether revascularization of a stenotic renal artery plus optimum medical therapy is associated with improved clinical outcomes when compared with optimum medical therapy alone.
Specific Aims, Design and Methods: Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) is a randomized clinical trial that will contrast the effect of optimum medical therapy alone to stenting with optimum medical therapy, on a composite cardiovascular and renal endpoint: cardiovascular or renal death, myocardial infarction, hospitalization for congestive heart failure, stroke, doubling of serum creatinine level, and need for renal replacement therapy. This endpoint will be adjudicated by a clinical events committee masked to treatment assignment. The secondary endpoints 1) evaluate the mechanisms linked to clinical events; 2) describe differential effectiveness in critical end-organs; 3) determine the value of stenting from the patient and the health policy perspectives, measured as quality of life and cost effectiveness; and 4) evaluate for clinically relevant differences in treatment effectiveness within the primary endpoint. The primary entry criteria are an atherosclerotic renal stenosis >60% with a 20 mmHg systolic pressure gradient and systolic hypertension >155 mmHg on 2 or more anti-hypertensive medications. A slight predominance of women is expected, and high priority will be placed on minority recruitment. Approximately 2200 patients will undergo a baseline evaluation with randomization occurring in 1080. The study has 90% power to detect a 28% reduction in primary endpoint hazard rate. This R01 from the Clinical Coordinating Center describes the main study hypotheses and overall trial conduct.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HL071556-01A1
Application #
6764629
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Reid, Diane M
Project Start
2004-04-01
Project End
2010-03-31
Budget Start
2004-04-01
Budget End
2005-03-31
Support Year
1
Fiscal Year
2004
Total Cost
$2,068,167
Indirect Cost
Name
University of Toledo
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
807418939
City
Toledo
State
OH
Country
United States
Zip Code
43614
Roumelioti, Maria-Eleni; Glew, Robert H; Khitan, Zeid J et al. (2018) Fluid balance concepts in medicine: Principles and practice. World J Nephrol 7:1-28
Lakhani, Hari Vishal; Khanal, Tilak; Gabi, Alaa et al. (2018) Developing a panel of biomarkers and miRNA in patients with myocardial infarction for early intervention strategies of heart failure in West Virginian population. PLoS One 13:e0205329
Liu, Jiang; Lilly, Megan N; Shapiro, Joseph I (2018) Targeting Na/K-ATPase Signaling: A New Approach to Control Oxidative Stress. Curr Pharm Des 24:359-364
Haller, Steven T; Kumarasamy, Sivarajan; Folt, David A et al. (2017) Targeted disruption of Cd40 in a genetically hypertensive rat model attenuates renal fibrosis and proteinuria, independent of blood pressure. Kidney Int 91:365-374
Goguet-Rubio, Perrine; Klug, Rebecca L; Sharma, Dana L et al. (2017) Existence of a Strong Correlation of Biomarkers and miRNA in Females with Metabolic Syndrome and Obesity in a Population of West Virginia. Int J Med Sci 14:543-553
Srikanthan, Krithika; Klug, Rebecca; Tirona, Maria et al. (2017) Creating a Biomarker Panel for Early Detection of Chemotherapy Related Cardiac Dysfunction in Breast Cancer Patients. J Clin Exp Cardiolog 8:
Santhanam, Prasanna; Shapiro, Joseph I; Khitan, Zeid (2017) Association between dietary potassium, body mass index, and proteinuria in normotensive and hypertensive individuals: Results from the Modification of Diet in Renal Disease study baseline data. J Clin Hypertens (Greenwich) 19:558-559
Tuttle, Katherine R (2017) Back to the Future: Glomerular Hyperfiltration and the Diabetic Kidney. Diabetes 66:14-16
Liu, Jiang; Yan, Yanling; Nie, Ying et al. (2017) Na/K-ATPase Signaling and Salt Sensitivity: The Role of Oxidative Stress. Antioxidants (Basel) 6:
Wang, Xiaoliang; Chaudhry, Muhammad A; Nie, Ying et al. (2017) A Mouse 5/6th Nephrectomy Model That Induces Experimental Uremic Cardiomyopathy. J Vis Exp :

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